FDA label fcf4b978-3a77-440f-b93a-e92dc9d4dce5

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
991fb1d2-eb44-4ab7-904e-79476b2190f0
SPL ID
fcf4b978-3a77-440f-b93a-e92dc9d4dce5
Version
6
Effective date
2018-12-06
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:24:46

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

5. WARNINGS AND PRECAUTIONS 5.1. Rx ONLY. 5.2. Do not use unless solutions are clear and free from particulates. 5.3. Always inspect the blood bag set for leaks before use. 5.4. Avoid excessive heat and direct sunlight. Protect from freezing. 5.5. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). 5.6. It is normal to have condensation in the blister packaging. If the amount of moisture is greater than expected, check for leaks from the fluid-filled components of the blood bag set. 5.7. Use aseptic techniques. 5.8. Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose. 5.9. Do not touch needle after removing the needle cover. 5.10. Discard phlebotomy needle/donor tubing according to institutional standard operating procedures. 5.11. The AGELESS® (oxygen absorber packet, Mitsubishi Gas Chemical) contained in this package absorbs oxygen and generates heat on removal. Do not open and handle it with care. 5.12. Dispose of the AGELESS packet with the blister tray. 5.13. Do not dispose the AGELESS packet with wastes containing volatile or flammable materials. 5.14. Due to possible exposure to infectious agents in the handling of blood, take adequate precautions at all times to prevent exposure to and transmission of such agents. Follow your institution's standard operating procedures.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.